Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
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|ClinicalTrials.gov Identifier: NCT03680950|
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Upper Gastrointestinal Bleeding||Device: Upper Gastrointestinal Monitoring System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System|
|Actual Study Start Date :||October 12, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Upper Gastrointestinal Monitoring System
Participants who meet criteria of enrollment and is willing to join in this study will wear a real-time upper gastrointestinal monitoring system for checking whether upper gastrointestinal rebleeding occurs continuously for 3 days.
Device: Upper Gastrointestinal Monitoring System
Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.
- Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index. [ Time Frame: 3 days ]The real-time upper gastrointestinal monitoring system is compared with the current monitoring index. The efficacy is estimated by which monitoring method finding the upper gastrointestinal rebleeding first.
- The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index. [ Time Frame: 3 days ]The accuracy of the current monitoring index and the real-time upper gastrointestinal monitoring system is compared. The accuracy is estimated by calculating the ratio of the number of making false alarm and the number of finding re-bleeding right.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680950
|Contact: Chiao-Hsiung Chuang, MD||886-6-2353535 ext firstname.lastname@example.org|
|National Cheng Kung University Hospital||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Chiao-Hsiung Chuang, MD|